FDA Recall
Ongoing2026 recordClass II
Optase Dry Eye Intense Drops (Glycerin 0.2%), packaged in 0.33 fl oz, Sterile, Manufactured for Scope Health Inc., 79 Madison Ave., 8th Floor, New York, NY 10016, USA, NDC 72972-002-01.
by SCOPE HEALTH
- Reason
- Lack of Assurance of Sterility
- Published
- May 6, 2026
- Distribution
- Nationwide
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FDA Recall
Ongoing2026 recordClass III
Levocarnitine Injection, USP, 1 g/5 mL (200 mg/mL), 5 mL Single-Dose Vial, For intravenous use, Rx Only, American Regent, Inc., Shirley, NY 11967. NDC: 0517-1045-01
by American Regent, Inc.
- Reason
- Labeling: Missing Label
- Published
- May 6, 2026
- Distribution
- Nationwide
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FDA Recall
Ongoing2026 recordClass II
GenTeal Tears, Lubricant Eye Gel, Sterile, 10g (0.34 Fl oz), Distributed by: Alcon Laboratories, Inc., Fort Worth, Texas 76134, USA, NDC: 0065-8064-01.
by Alcon Research LLC
- Reason
- Lack of Assurance of Sterility: Due to FDA inspection observations that it believes may impact product quality.
- Published
- May 6, 2026
- Distribution
- Nationwide
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FDA Recall
Ongoing2026 recordClass II
Systane, Lubricant Eye Gel, Night Gel, Sterile, 10g (0.35 oz), Processed in France for: Alcon Laboratiroes, Inc., Fort Worth, TX 76134, USA, NDC 0065-0474-01
by Alcon Research LLC
- Reason
- Lack of Assurance of Sterility: Due to FDA inspection observations that it believes may impact product quality.
- Published
- May 6, 2026
- Distribution
- Nationwide
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FDA Recall
🇺🇸 United States
Ongoing2026 recordClass I
HEMU TRADING INC
- Product
- Black label with blue lettering. FOOD Korean Food, ENOKI MUS…
- Reason
- product tested positive for Listeria Monocytogenes.
- Published
- May 6, 2026
- Distribution
- 5 direct account consignees located in C…
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FDA Recall
🇺🇸 United States
TerminatedTerminated: July 10, 20262026 recordClass II
King Juice Company, Inc.
- Product
- Calypso Tropic Tango Lemonade. 16 FL oz (1PT) (473 ML). UP…
- Reason
- Product contains undeclared Yellow No. 5.
- Published
- May 6, 2026
- Distribution
- Nationwide
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FDA Recall
🇺🇸 United States
TerminatedTerminated: May 19, 20262026 recordClass II
The Mochi Ice Cream Company, LLC
- Product
- My Mochi Strawberry flavored Non-Dairy Frozen Dessert; 7.5 o…
- Reason
- Foreign object found inside retail container.
- Published
- May 6, 2026
- Distribution
- Nationwide
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FDA Recall
🇺🇸 United States
Completed2026 recordClass II
Ganesha Enterprises LLC
- Product
- KLG, Kesar Mukhwas, perishable, 24 months, flexible plastic,…
- Reason
- Undeclared food colorings (Yellow 6, Blue 1, and Yellow 5) and unapproved Acid Red 14.
- Published
- May 6, 2026
- Distribution
- Product was distributed in the following…
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FDA Recall
🇺🇸 United States
TerminatedTerminated: July 9, 20262026 recordClass II
LACTALIS CANADA, INC
- Product
- Specially SELECTED brand Vanilla Creme Brulee; NET WT 3.6oz…
- Reason
- Product may contain foreign objects, specifically glass.
- Published
- May 6, 2026
- Distribution
- NY, IN, FL, IL, VA, MD, and MI
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FDA Recall
Ongoing2026 recordClass II
Claravis (isotretinoin capsule, USP), 10 mg, Packaged as a) 100-count carton, NDC 0555-1054-56, with 10x10 blister packs NDC 0555-1054-60; b) 30-count carton, NDC 0555-1054-86, with 3X10 blister pack NDC 0555-1054-60; Rx only, Teva Pharmaceuticals USA, Inc., North Wales, PA 19454.
by Teva Pharmaceuticals USA, Inc
- Reason
- Failed Impurities/Degradation Specifications: Out of specification for specific impurity Tretinoin
- Published
- April 29, 2026
- Distribution
- Nationwide
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FDA Recall
Ongoing2026 recordClass II
LACTATED RINGER'S IRRIGATION, 3000 mL bags, Sterile, Ex only, B. Braun Medical Inc., Bethlehem, PA 18018-3524, USA, NDC: 0264-7389-60.
by B BRAUN MEDICAL INC
- Reason
- Lack of Assurance of Sterility; potential for leakage from the diaphragm port once the foil is removed.
- Published
- April 29, 2026
- Distribution
- Nationwide
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FDA Recall
Ongoing2026 recordClass II
0.9 % SODIUM CHLORIDE IRRIGATION, USP, 3000 mL bags, Rx only, Sterile, B. Braun Medical Inc., Bethlehem, PA 18018-3524, USA, NDC: 0264-7388-60.
by B BRAUN MEDICAL INC
- Reason
- Lack of Assurance of Sterility; potential for leakage from the diaphragm port once the foil is removed.
- Published
- April 29, 2026
- Distribution
- Nationwide
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FDA Recall
Ongoing2026 recordClass II
DEXTROSE INJECTION USP, 70%, 2000 mL bags, Rx only, Sterile, B. Braun Medical Inc., Bethlehem, PA 18018-3524, USA, NDC: 0264-7387-50.
by B BRAUN MEDICAL INC
- Reason
- Lack of Assurance of Sterility; potential for leakage from the diaphragm port once the foil is removed.
- Published
- April 29, 2026
- Distribution
- Nationwide
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FDA Recall
Ongoing2026 recordClass II
Sterile Water for Injection USP, 3000 mL bags, Rx only, Pharmacy Bulk Package, B. Braun Medical Inc., Bethlehem, PA 18018-3524, NDC: 0264-7385-60.
by B BRAUN MEDICAL INC
- Reason
- Lack of Assurance of Sterility; potential for leakage from the diaphragm port once the foil is removed.
- Published
- April 29, 2026
- Distribution
- Nationwide
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FDA Recall
Ongoing2026 recordClass III
Premier, Monsel's, Ferric Subsulfate Solution, 8 mL bottles, Rx only, Manufacturer: Premier Medical Products, 1710 Romano Drive, Plymouth Meeting, PA 19462, NDC 48783-112-08.
by Premier Dental Products Co
- Reason
- Labeling: Incorrect or Missing Lot and/or Exp Date:The expiration date has an extra digit and is printed as 2709114 instead of the correct 270914 (2027-09-14). It is important to note that this error is limited to the vial itself; the saleable unit of the box of 12 bottles has the correct expiration date printed.
- Published
- April 29, 2026
- Distribution
- Nationwide
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FDA Recall
Ongoing2026 recordClass II
FRESHKOTE LUBRICANT EYEDROPS, Sterile, 0.33 FL OZ (10mL), Harrow Eye LLC, Nashville, TN USA.
by Harrow Eye LLC
- Reason
- Lack of Assurance of Sterility
- Published
- April 29, 2026
- Distribution
- Nationwide
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FDA Recall
Ongoing2026 recordClass II
Furosemide Tablets, USP, 80 mg, 100 Tablets bottles, Rx only, Manufactured by: Leading Pharma, LLC, Fairfield, NJ 07004, NDC 69315-118-01
by Leading Pharma, LLC
- Reason
- CGMP Deviations; presence of N-nitroso-Furosemide (NNF) above the recommended intake limit.
- Published
- April 29, 2026
- Distribution
- Nationwide
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FDA Recall
Ongoing2026 recordClass II
Pantoprazole Sodium, Delayed-Release Tablets, USP, 40 mg, 1000-count bottle, Rx only, Manufactured for: Camber Pharmaceuticals, Inc., Piscataway, NJ 08854, By: Hetero, Hetero Labs Limited, Unit V, Polepally, Jadcherta, Mahabubager-509 301, India, NDC 31722-713-10
by Hetero Labs Limited (Unit V)
- Reason
- Discoloration: Firm received five (5) complaints stating that, "Tablets discolored darker than normal and have lighter-colored spots."
- Published
- April 29, 2026
- Distribution
- Nationwide
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FDA Recall
Ongoing2026 recordClass II
Omega-3-Acid, Ethyl Esters, Capsules, USP, 1 gram, 50 capsules (5 x 10 unit dose blister cards) per carton, Rx only, Packaged and Distributed by: Major Pharmaceuticals, Indianapolis, IN 46288. NDC: 0904-7495-06
by The Harvard Drug Group LLC
- Reason
- Failed Capsule Specifications: Out of specification results obtained during routine stability testing for Loss on Drying of Capsule Shells.
- Published
- April 29, 2026
- Distribution
- Nationwide
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FDA Recall
🇺🇸 United States
TerminatedTerminated: June 30, 20262026 recordClass I
Costco Wholesale Corporation
- Product
- Kirkland Signature Traditional Madeleines 12 Count/net wt. 1…
- Reason
- Undeclared hazelnut and soy lecithin.
- Published
- April 29, 2026
- Distribution
- Distributed in CA, CO, FL, IL, MT, VA, W…
View recall →
Recall records are summarized from official FDA and USDA sources. Notices may be updated, reclassified, terminated, or withdrawn. Always review the linked official notice for the most current instructions.
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